Prospective observational study for Treatment resistance related gene screening using plasma circulating tumor DNA in the third generation EGFR-TKI Osimertinib therapy - Elucidator

Tamiya Akihiro0 sites180 target enrollmentDecember 10, 2018

Overview

No summary available.

Registry

who.int

Start Date

December 10, 2018

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Tamiya Akihiro

•1\) Cases in which a definitive diagnosis of non\-squamous non\-small cell lung cancer has been obtained by histological examination or cytological examination.
•2\) Cases of inoperable or recurrent non\-small cell lung cancer positive for EGFR\-TKIs susceptibility gene mutation.
•3\) Cases in which osimertinib monotherapy is used as the initial treatment.
•4\) Plasma samples can be submitted.
•5\) Written consent has been obtained.

•1\) Cases that the doctor in charge deems inappropriate for this study
•2\) Cases with experience of allogeneic bone marrow transplantation
•3\) Cases scheduled for non\-leukocyte depletion whole blood transfusion
•4\) Cases where the consent of the person cannot be obtained
•5\) Minors under the age of 20
•6\) Cases of inoperable or recurrent non\-small cell lung cancer with negative EGFR\-TKIs susceptibility gene mutations (without exon19del, exon21L858R)
•7\) Cases less than 1 year after postoperative chemotherapy
•8\) Cases of treatment containing drugs other than osimertinib